FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Penis, Inflatable
PMA: N970012
·
Supplement: S135
·
Decision Jun 16, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Penis, Inflatable
- Trade Name
- Ambicor Implantable Penile Prosthesis
- PMA Number
- N970012
- Supplement Number
- S135
- Device Class
- FDA Class 3
- Product Code
- JCW
- Generic Name
- Prosthesis, penis, inflatable
- Regulation Number
- 876.3350
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 16, 2017
- Date Received
- May 17, 2017
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for an addition of a manufacturing inspection step.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JCW | Prosthesis, Penis, Inflatable | FDA class 3 | Gastroenterology, Urology |